Cleared Traditional

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators

K200248 · Allwin Medical Devices, Inc. · Obstetrics & Gynecology
Jul 2020
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K200248 is an FDA 510(k) clearance for the Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Allwin Medical Devices, Inc. (Anaheim, US). The FDA issued a Cleared decision on July 1, 2020, 152 days after receiving the submission on January 31, 2020. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number K200248 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2020
Decision Date July 01, 2020
Days to Decision 152 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MQF — Catheter, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6110

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